Merck & Co's non-U.S. business, MSD, reported approval throughout the EU for Sycrest®, a sublingual asenapine drug for treating moderate to severe manic episodes in adult patients with bipolar I disorder. Sycrest was first approved in the U.S. in 2009, where it is marketed as Saphris® for the treatment of schizophrenia and mania in bipolar disorder.
EU approval was based on data from trials involving some 1,300 patients with bipolar mania. Studies included two montherapy trials comparing Sycrest with olanzapine and placebo and a 326-patient study evaluating the drug as adjuctive therapy to lithium or valproate.
The results of the 12-week placebo-controlled trial found that giving asenapine to patients who were partially nonresponsive to lithium or valproate monotherapy resulted in improved reduction of manic symptoms compared to what either approved drug could achieve when given alone.